Venous Versus Arterial Blood Gas Sampling in Undifferentiated Emergency Patients

June 15, 2022 updated by: Daniel Wilhelms, University Hospital, Linkoeping

In the emergency department and intensive care unit, blood gas analysis is a crucial tool in the assessment of critically ill patients. Blood gas analysis is quick and repeatable at the bedside. The sampling can be done from both arterial and venous samples, with arterial samples generally considered to be more reliable and by that widely used as the standard method.

The purpose of this project is to compare venous and arterial blood gas parameters in undifferentiated, critically ill patients. We plan to evaluate the correlation between different parameters through a prospective observational study. In particular, carbon dioxide partial pressure (pCO2) correlation between venous and arterial samples is investigated by using and comparing different conversion models proposed in the literature.

250 patients deemed to be in need of arterial blood gas sampling based on their clinical condition will be included in a consecutive fashion at all hours.

The long-term goal is to clinically translate the findings into a limitation on the use of arterial sampling, which could potentially reduce pain and complication risks in the many patients who undergo arterial blood gas sampling every day.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

== Practical procedures & flowchart ==

Patients included in this study are treated according to clinical routine. After inclusion, sampling of an arterial blood gas and a venous blood gas is performed simultaneously or as close in time as possible. Because the venous blood gas analysis sample can be taken directly from the patient's peripheral venous catheter, no additional venous puncture is usually required and the additional amount of blood that may be required is approx. 1 ml (the assay requires about 500 µl). In the very rare cases where it is not possible to establish a peripheral venous catheter within a reasonable time, the sample will be acquired from a new venous puncture together with other venous routine samples.

Sampling can be carried out by doctors or nurses. The arterial and venous blood gas analysis is performed with a blood gas analyzer (ABL90) in the emergency department and is performed immediately after the sampling. Sampling times and analysis times are documented.

Survey results are routinely stored in electronic form in patient health record and also locally on the device ABL90 with social security number as ID. The data is saved for statistical analysis.

== Documentation ==

The following parameters are documented during sampling:

  • Chief complaint
  • Indication for sampling
  • The patient's current vital signs at the time of sampling
  • Ongoing oxygen treatment (flow rate)
  • Size of cannula, sampling location
  • Sampling times and analysis times
  • Number of puncture attempts

After sampling, the following is documented:

  • Analysis results of venous and arterial blood gas sample
  • Final diagnosis at discharge from the emergency department

The documentation will primarily be on worksheets, which will be marked with a patient label (name / social security number) and a serial number. The worksheet will be stored together with consent forms in a locked space of Akutkliniken US Linköping.

The data will be archived in the local emergency department or at the Regional Archives in Östergötland according to applicable laws and regulations.

The result of blood gas analysis is obtained from the digital lab system in the patient record (Lab-ROS) or directly exported from the internal memory of the analyzers at the emergency department. In both cases, the results will be used for digital compilation of study data. All electronic storage of study data will be pseudonymized by linking to patients serial number.

== Statistics ==

In previous studies, the correlation between arterial and venous samples has been evaluated using several different statistical methods:

  • T-test, Pearson's and Spearman's R variable
  • Descriptive data are presented as mean and +/- from SD

Our intention in this study is to make a parallel comparison of previously published methods, as well as to examine, based on collected data, whether a new formula with better precision can be derived.

== The potential significance of the project ==

At present, arterial blood gas sampling is used as the standard procedure for assessing a critically ill patient in the emergency department.

The project aims to clarify the feasibility of replacing routine arterial blood gas sampling in the emergency department with venous punctures without impairing test results and patient care. If feasible, such a change in sampling routines could potentially mean a great improvement for patients in terms of pain and complication risks. Also, workflow and lead times in the emergency department could be improved by the fact that venous samples may be drawn by all clinical staff, whereas arterial samples are normally reserved for doctors and nurses with dedicated training.

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Östergötland
      • Linköping, Östergötland, Sweden, 58185
        • University Hospital Linköping

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

For enrolment, we will consider all patients who are admitted to the emergency department irrespective of mode of arrival (ambulance, walk-in etc). To be eligible, patients will need to be classified as critical ill and there has to be a clear clinical indication for an arterial blood gas sampling. Indications for arterial blood gas sampling, in turn, are primarily dictated by local SOPs (Standard Operating Procedures; "PM/ vårdprocessåtgärder") for appropriate sampling based on chief complaint, age, and vital signs upon arrival. The aim is to include these patients consecutively around-the-clock.

Description

Inclusion Criteria:

  • Patients able to understand and process oral and written information and give his/her consent (within 12h), or consent provided by a close relative.
  • Aged > 18 years
  • Assessed to be in need of arterial blood gas analysis

Exclusion Criteria:

  • Unwilling to participate, or unable to understand the provided information
  • Inability to give subsequently consent (> 12 hours) or unwillingness by close relative to provide consent.
  • Pregnant
  • Aged < 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Indication for blood gas sampling
To be eligible, patients will need to be classified as critically ill and there has to be a clear clinical indication for an arterial blood gas sampling. Enrollment will be performed in a consecutive manner at all hours.
Diagnostic test: Blood gas sampling from artery and vein
Patients included in this study are treated according to clinical routine. After inclusion, sampling of an arterial blood gas and a venous blood gas is performed simultaneously or as close in time as possible. Because the venous blood gas analysis sample can be taken directly from the patient's peripheral venous catheter, no additional venous puncture is usually required and the additional amount of blood that may be required is approx. 1 ml (the assay requires about 500 µl). In the very rare cases where it is not possible to establish a peripheral venous catheter within a reasonable time, the sample will be acquired from a new venous puncture together with other venous routine samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
How does pCO2 correlate between arterial and venous blood gas samples?
Time Frame: October - November 2020
October - November 2020
Can a clinically reliable correlation be identified using a conversion model? (existing or new)
Time Frame: October - November 2020
October - November 2020

Secondary Outcome Measures

Outcome Measure
Time Frame
How does processing times and sampling location affect the result?
Time Frame: October - November 2020
October - November 2020
How does the patient's vital parameters (blood pressure, pulse) affect the results?
Time Frame: October - November 2020
October - November 2020
In there a difference in the analysis results between the emergency department and the central laboratory?
Time Frame: October - November 2020
October - November 2020
How reliable are the results beyond mild to moderate deviations from normal values in consecutive enrolled, critically ill patients?
Time Frame: October - November 2020
October - November 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Linkoeping

Investigators

  • Principal Investigator: Matthias Jörg, MD, Emergency Department, University Hospital Linköping, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2021

Primary Completion (Actual)

March 27, 2022

Study Completion (Actual)

March 27, 2022

Study Registration Dates

First Submitted

May 26, 2020

First Submitted That Met QC Criteria

May 26, 2020

First Posted (Actual)

June 1, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2022

Last Update Submitted That Met QC Criteria

June 15, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SE2020-00396

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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